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Director – Regulatory Affairs Strategy
| Company | AstraZeneca |
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| Location | Gaithersburg, MD, USA |
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| Salary | $186232.8 – $279349.2 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Senior |
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Requirements
- Bachelor’s Degree in Life Science or related discipline, advanced degree a plus.
- 5+ years of proven experience defining and implementing the regulatory strategy for a pharmaceutical organization.
- Extensive knowledge of regulatory affairs within one or more therapeutic areas in early and late development
- Proven track record of regulatory drug development including product approval/launch.
- Experience in leading Major Health Authority interactions
- Ability to think strategically and critically and evaluate risks to regulatory activities.
- Ability to work strategically within a complex, business critical and high-profile development program.
Responsibilities
- Provide strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned products.
- Serve as the global regulatory lead (GRL) on projects or specific indications of larger programs and/or as the regional regulatory lead.
- Craft and implement the clinical strategy and influence health authorities to improve outcomes.
- Define the regulatory strategy for therapeutic assets and engage with Health Authorities to inform development programs.
Preferred Qualifications
No preferred qualifications provided.
